At Otsuka and on our team, we believe creativity is everything. Without innovation, there is no real growth. That is why Otsuka is looking for people, not roles.
- Think differently by challenging conventional thinking - Are intellectually curious and life-long learners
- Are effective, 'get it done' and have a sense of ownership
- Are comfortable with ambiguity, autonomy and recognize that innovation is at its best when people connect
- Are remarkable in their chosen field Key
At Otsuka, we are committed to product safety and are looking for an MD that shares our passion for ensuring all activities are of the highest safety and ethical standards. The Director of Clinical Safety and Pharmacovigilance
will lead product safety teams in all aspects of pharmacovigilance and risk management activities for assigned products, both marketed and in development. Key activities include medical analysis and decision making for the development and maintenance of the Company Core Data Sheet, ad hoc aggregate safety reports, periodic safety update reports (PSURs), signal detection activities, and reports risk management plan (RMPs/REMS) and individual case safety reports. He/she will work in cross-functional teams with counterparts in regulatory, clinical development, pre-clinical, manufacturing/quality, global pharmacovigilance and, other functional areas to identify, evaluate and communicate safety issues relevant to his/her assigned products.Responsibilities:
- Analysis of comprehensive product information, synthesis, risk-benefit assessment and, reporting
- Proactive Monitoring of product safety profile from FIH throughout the lifecycle
- Primary ownership and accountability for product signaling review, analysis, delivery and approval
- Timely action and communication of finding safety governance forums
- Leadership and ownership of internal safety governance bodies (SMT, JSMT). Active contribution to internal and external forums (e.g., DMC, Advisory Boards)
- Contribution and review of safety documents from individual patient data to submission-level safety documents
- Partnership with GCD Project Leaders on Program Development from Phase I to LCM regarding safety and risk-benefit topics and decisions, including contribution and review of new drug approval filing documents
- Contribute to label development, scientific regulatory responses. Review and Approve Coding.
- Active, Regular Utilization of Data Review, Reporting and Visualization Tools & Systems.
- Provide medical and PV oversight and key input to: Protocols, Investigator Brochures, Safety Summaries, Clinical Study Reports, Regulatory Reports (periodic, ad hoc), Labeling changes
- Train drug safety associates and contribute to mentoring and on-boarding of new colleagues
- Serve as the subject matter expert from a safety perspective
- Work extensively with colleagues from across the globe
- Participate in department decision making and strategy
- Ensure all activities are of the highest safety and ethical standards
- Knowledge, Skills, Competencies, Education, and Experience
- Requires a strong medical background evidenced by clinical training
- Solid knowledge of FDA and global PV regulations.
- Knowledge of clinical trials, good clinical practices, and ICH guidelines.
- Oncology or Neurology experience a plus
- Experience in working in a global setting
- Experience with industry software and databases.
- Sound computer skills and be well versed in the use of Microsoft Office
- Excellent verbal and written communication skills
- Good presentation skills
Education and Related Experience
- Self-starter with proven ability to thrive in a fast-paced team environment handling multiple simultaneous high priority tasks
- Strong leadership skills
- Ability to adapt to a dynamic work environment
- MD degree with US medical license (preferred)
- Demonstrated experience (at least 5-7 years) as a Safety/PV professional in a pharmaceutical industry
- Experience with both development and product launch/post marketed products preferred.
- Ability to act as in-house authority/leader in Safety and Pharmacovigilance; and be fully accountable for the Safety of assigned products.
- Experience interacting with global regulatory authorities.
- Physical Demands and Work Environment
- Travel (approximately 10-15%)
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Statement Regarding Job Recruiting Fraud Scams
Job postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External
. Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.
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